Oversight, Expertise, and Ability to Successfully Publish eSubmissions to the FDA
Due to increasing regulatory agency requirements, Veristat delivers regulatory publishing support as part of our regulatory application solution. Our clients benefit from having end-to-end services – the same team works on your program from a regulatory, CMC and clinical perspective, writes your regulatory documents, and then submits them through the ESG to the FDA.
Our publishing experts provide:
- Project and timeline management for the regulatory publishing process
- Conversion from paper submissions to eCTD format
- Use of standardized templates
- Document level publishing
- Word formatting: styles, captions, cross-references, tables, etc.
- Conversion of files to required standards
- PDF processing: bookmarks, internal links, PDF properties, QC
- Submission level publishing: eCTD placement, cross-document links, study tagging files (STF)
- Submission quality control (QC)
- Transmission of submissions to FDA via Electronic Submissions Gateway
- Archive and document transfer: archival of final word docs and submission sequence